IBD-Control Questionnaire Research Articles

N05 Empowerment of patients with Inflammatory Bowel Disease: Effect on quality of life and disease control

Abstract Background Inflammatory bowel disease (IBD) is a chronic condition. The increasing number of cases and the diversity of treatments, significantly raises healthcare costs, making IBD a high-impact disease and a priority for healthcare systems. IBD deeply affects patients’ quality of life, impacting their physical, emotional, and social well-being. A crucial factor in improving this situation for both patients and healthcare systems is promoting self-care. Nurses play a vital role in educating patients and implementing self-care strategies. Enhancing patients’ knowledge of their disease and their ability to identify and manage symptoms is essential for effective control. Self-care activities are complex, requiring patients to become experts in various health-related aspects, including treatment adherence, adopting healthy lifestyle habits, and the ability to detect and respond to warning signs. The primary objective of this study is to analyse whether a higher degree of empowerment in IBD patients is associated with more effective disease control and improvements in their quality of life and emotional well-being. Methods A descriptive observational cross-sectional study was conducted with consecutive sampling, including a total of 75 patients. Various measurement instruments were used for data collection, including the Harvey Bradshaw Index (HBI) and the Partial Mayo Score (PMS) for assessing disease activity; the Chronic Disease Patient Empowerment Questionnaire (CEPEC); the IBDQ-9 questionnaire to evaluate IBD-related quality of life; and the IBD-Control questionnaire to measure perceived disease control. Results A total of 75 patients diagnosed with inflammatory bowel disease (IBD) were analyzed, of whom 62% were male and 38% female. The mean age of participants was 48 years. A notable finding was that 62% of patients exhibited a high degree of empowerment. Among these highly empowered patients, 62% scored above 12 points on the IBD-Control questionnaire, indicating greater perceived control over their disease. Regarding quality of life, as assessed by the IBDQ-9 questionnaire, the mean global score among patients was 77 points, reflecting a high perception of quality of life within this population. Conclusion Patients with greater empowerment have more effective control of their IBD. A high degree of empowerment is associated with better quality of life and greater emotional stability. Empowerment contributes to fewer hospitalisations and severe complications, which also reduces the economic burden on the healthcare system. This suggests that promoting self-care education programmes led by advanced practice nurses could be a cost-effective strategy, improving disease self-management and contributing to greater satisfaction and quality of life. References •Abraham C, Cho JH. Inflammatory bowel disease. N Engl J Med. 2009;361(21):2066-2078. doi:10.1056/NEJMra0804647 •Garcimartin P, Pardo-Cladellas Y, Verdú-Rotellar JM, Delgado-Hito P, Astals-Vizcaino M, Comin-Colet J. Adaptación transcultural al español del cuestionario Patient empowerment in long-term conditions. Atención Primaria. 2019 Jan;51(1):24–31.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7956493/ • Ostromohov G, Fibelman M, Hirsch A, Ron Y, Cohen NA, Kariv R, et al. Assessment of patients’ understanding of inflammatory bowel diseases: Development and validation of a questionnaire. United European Gastroenterology Journal [Internet]. 2021 Dec 23 [cited 2022 Sep 8];10(1):104–14. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8830304/

P0793 Correlation between patient centred disease control versus biochemical parameters in IBD

Abstract Background Subjective patient experiences related to treatment are frequently underreported by healthcare providers, leading to potential discrepancies between patients and physicians in defining remission. This can influence patient expectations, engagement behaviours, and ultimately clinical outcomes. Based on these findings, the treatment approach for IBD has evolved, with the STRIDE-II consortium incorporating disease control from the patient perspective into the long-term treatment goals established in STRIDE-I. This study aims to compare subjective disease control assessed with patient reported outcome measures (PROMs) to objective biochemical parameters after starting Vedolizumab or Ustekinumab for the treatment of active disease. Methods Patients with IBD starting Vedolizumab or Ustekinumab included in the remote monitoring care-path with myIBDcoach were eligible for inclusion. Follow-up was 48 weeks and patients completed questionnaires at least once every 16 weeks. The IBD-control questionnaire and Monitor IBD At Home (MIAH) questionnaire were used as PROMs for disease control and clinical disease activity. The cut-off value of disease activity assessed with the MIAH questionnaire was >3.5 for ulcerative colitis and >3.6 for Crohn’s disease. Biochemical parameters C-reactive protein (CRP) and faecal calprotectin (FCP) were also measured every 16 weeks. The correlation per follow-up moment between IBD control and clinical remission measured with MIAH questionnaire, CRP and FCP was analysed with bivariate correlation tests. The longitudinal correlation between IBD control and clinical remission was assessed with linear mixed models (LMM). Results 70 patients were included in the analyses. 25 and 46 patients started Vedolizumab or Ustekinumab, respectively (Table 1). At baseline, the mean IBD-control score was 8.5 (SD 4.7). 38% of the patients had active disease based on the MIAH questionnaire and median FCP and CRP at baseline were 369 (929) and 4 (15), respectively. IBD-control showed a moderate correlation of -0.50 with MIAH score at baseline (P=0.001). There was a weak and non-significant correlation of 0.10 and -0.09 between IBD-control with both FCP (P=0.459) and CRP (P=0.508), respectively. The LMM showed a fixed longitudinal effect between IBD-control and MIAH (P=0.006), whereas there was no fixed effect between FCP (P=0.221) and CRP (P=0.222). Conclusion In this explorative study, a significant correlation between IBD-control and a PROM for clinical disease activity was seen, whereas the correlation between IBD-control and objective biochemical parameters was low and not statistically significant. Treating physicians should be aware of the discrepancy between clinical and biochemical indicators of disease activity in IBD.

P0744 Observational Real-World Study of Switching from Intravenous to Subcutaneous Vedolizumab in IBD Patients: Clinical and Pharmacokinetic Analysis

Abstract Background Following the introduction of subcutaneous vedolizumab (VDZ-sc), which demonstrated efficacy in maintaining remission after two intravenous (iv) induction doses, a real-world approach was proposed to switch stable patients undergoing intravenous vedolizumab (VDZ-iv) treatment to the subcutaneous formulation. Aims To prospectively evaluate the switch from VDZ-iv to VDZ-sc in stable IBD patients receiving maintenance therapy with VDZ-iv. Methods A prospective study was conducted across three centers, including stable patients on maintenance VDZ-iv who opted to switch to VDZ-sc and consented to participate. Demographic data, IBD characteristics, and details of VDZ treatment were collected. Three evaluation points were established: baseline (at the time of switching), 6 months, and 12 months. During each visit patients completed two PRO questionnaires (IBD-Control and WPAI); also clinical data (Harvey-Bradshaw Index (HBI) for Crohn's Disease, partial Mayo score (pMS) for Ulcerative Colitis), biological data (fecal calprotectin (FC), CRP), and VDZ trough levels were collected. Results A total of 17 IBD patients were included, 70% had Ulcerative Colitis, with a median duration of 9,7 years. VDZ-iv was the second line of therapy in 58% of patients. Six patients (35.3%) had intensified VDZ-iv dosing. Upon switching, VDZ-sc dosage was intensified in 5 patients (Table 1). At baseline, 10 patients were in remission (HBI ≤4, pMS ≤1) with CF <250. 12 patients (70,6%) had a score on the IBD-control ≥13, and it remained stable. Among the 12 patients able to work, 6 were actively employed. In these patients, the impact of IBD on work was low across all visits. VDZ Trough levels were significantly higher at 6 and 12 months compared to baseline. No other variables showed differences. At baseline, 4 patients (23.5%) doubted whether their IBD was controlled and/or if VDZ treatment was useful (questions 1 and 2 of the IBD-Control questionnaire). All of these patients had mild clinical and biological activity. By month 6, two of them were switched (one to intensified VDZ-iv and the changed to ustekinumab). Additionally, another patient lost response during the switch to biweekly VDZ-sc dosing, and was reverted to intensified VDZ-iv, subsequently regaining response. The persistence of VDZ-sc at one year was 82.3%, while the overall persistence of VDZ (both iv and sc) was 94.1%. Conclusion VDZ-sc is effective in maintaining the response achieved with VDZ-iv, with high persistence at one year. Patients’ perception of the treatment's utility and IBD control was positive and remained consistent during the switch. Patients with a perception of poor control and lack of deep remission at baseline are at higher risk of losing response when switching to VDZ-sc.

Validation of the Portuguese Version of IBD-Control Questionnaire and Comparison with IBD-Disk

Introduction: The IBD-Control questionnaire and IBD-Disk are two patient-reported outcome measures designed to evaluate the impact of inflammatory bowel disease (IBD) on different health domains. Unlike IBD-Disk, there is no fully published validated Portuguese version of IBD-Control. Furthermore, the two instruments have not yet been compared. We aimed to translate and validate IBD-Control in Portugal and compare it with IBD-Disk. Methods: After translation into Portuguese, the IBD-Control was administered to IBD patients, at baseline (T0), after 1–4 weeks (T1), and >3 months (T2). Patients also completed the Portuguese versions of the PRO2, EQ-5D, SIBDQ, and IBD-Disk. We assessed the reliability, validity, responsiveness, and interpretability of IBD-Control. We compared the usability (3 questions) and the ability to identify good disease control (area under the curve [AUC]) of IBD-Control and IBD-Disk. Results: At T0, the IBD-Control was completed by 142 patients (108 Crohn’s disease, 34 ulcerative colitis). At T1 and T2, 68 and 101 patients completed the questionnaire, respectively. Factor analysis confirmed the one-dimensionality of the scale with 8 items (IBD-Control-8). Internal consistency (Cronbach’s alpha) was 0.80. Test-retest reproducibility for stable patients (n = 54) was high (intraclass correlation coefficient-0.86). IBD-Control-8 significantly correlated (r between 0.55 and 0.82; p ≤ 0.001) with PRO2, EQ-5D, SIBDQ and IBD-Disk. The variation in IBD-Control-8 between T0 and T2 correlated significantly (r between 0.48 and 0.53; p ≤ 0.01) with the variation in PRO2 (only for Crohn’s disease), SIBDQ and IBD-Disk. The IBD-Control-8 significantly discriminated between well and poorly controlled disease (15 ± 2 vs. 11 ± 4; p < 0.001). No significant differences were observed between IBD-Control-8 and IBD-Disk regarding usability and the ability to identify good disease control (AUC: −0.79 vs. 0.76, respectively). Conclusions: The IBD-Control is reliable and valid for measuring disease control from the perspective of patients with IBD in Portugal, presenting no significant differences regarding usability and assessment of disease control when compared to IBD-Disk.

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS).

Patient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition. The aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5). iBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes. A total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity. This study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes. Number 2018-004967-30.

P984 VEST: The UK vedolizumab real life experience study in Inflammatory Bowel Disease

Abstract Background The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK. Methods Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events. Results Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1). Conclusion Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.

P344 Achieving Crohn's Disease treatment targets following the STRIDE-II recommendations in clinical practice

Abstract Background The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative proposes therapeutic targets for inflammatory bowel disease (IBD) to be used for a treat-to-target clinical management strategy. However, there is lack of information regarding how many patients actually achieve defined treatment targets as outlined in STRIDE-II after initiation of new therapies. The objective of this study was to investigate the treatment response of Crohn’s disease (CD) patients according to the STRIDE-II recommendations in the first year after starting a new pharmacological therapy in clinical practice. Methods CD patients included in a remote monitoring care-path using myIBDcoach, starting a new therapy between January 1st 2020 and December 31st 2021 were eligible for inclusion. The short-term (2-4 months) treatment target was defined as clinical response based on at least 50% decrease in the Monitor IBD at home (MIAH) questionnaire, a patient-reported outcome measure validated to predict endoscopic disease activity. Intermediate (5-9 months) targets were clinical remission (MIAH ≤3.6) and normalization of inflammatory parameters, i.e. faecal calprotectin (&amp;lt;150 ug/g) and C-reactive protein ([CRP] &amp;lt;10 mg/L). Long-term (10-12 months) targets were absence of disability (IBD-control questionnaire ≥13), and a combination of MIAH score ≤3.6 and calprotectin &amp;lt;150 ug/g as surrogate markers for endoscopic remission. Results 39 CD patients were included in the current analysis, of which two started treatment with thiopurines and 37 with a biological. At baseline, median MIAH score was 3.0 (IQR 3.1) and median IBD-control score was 8.5 (IQR 9.0). After three months of therapy, 26% of patients showed clinical response and 64% of patients were in clinical remission (median MIAH 2.2 [IQR 1.8]). As for intermediate targets, clinical remission was seen in 62% (median MIAH 2.0 [IQR 2.3]), and CRP and calprotectin normalization in 79% and 59% of patients, respectively. At the end of follow-up, 41% had low surrogate marker scores indicative for endoscopic remission (median MIAH 1.9 [IQR 1.6] and median calprotectin 109.0 [IQR 241.0]). Resolution of disability was achieved in 65% (median IBD-control score 14.0 [IQR 6.0]). Three patients (9%) achieved all treatment targets within a year of follow-up (Table 1). Conclusion This study used an incident user real-world cohort to evaluate the STRIDE-II recommendations. While all patients achieved at least one treatment target, only 9% achieved all treatment targets according to the STRIDE-II recommendations. Using these recommendations provides good guidance in clinical settings. However, treatment approaches need to be improved to reach the optimal outcomes in daily clinical practice.

Translation, cross-cultural adaptation and validation of the Chinese version of the IBD-Control questionnaire: A patient-reported outcome measure in inflammatory bowel disease.

A demand exists for user-friendly patient-reported outcome measures for patients with inflammatory bowel disease (IBD). The IBD-Control Questionnaire has been recently developed to assess overall disease control from the patient's view but has not been available in China. Translation and cultural adaption of the IBD-Control into Chinese was conducted through four steps (forward translation, backward translation, expert panel, and pilot testing). Afterwards, a prospective validation study was conducted from February 2022 to February 2023. The translated IBD-Control, Short Health Scale, EQ-5D-5L, and disease activity measurements using either the Physician Global Assessment and Simple Clinical Colitis Activity Index or the Crohn's Disease Activity Index were used. Acceptability, test-retest reliability, internal consistency, content validity, convergent validity, structural validity, discriminant ability, and receiver operating characteristic curves were analyzed. Questionnaires were completed by 150 participants with IBD (31 with Crohn's disease [CD] and 119 with ulcerative colitis [UC]). The Cronbach's alpha coefficient was 0.823 for the IBD-Control-8 scale. The correlations between individual item and total score varied from 0.485 to 0.892 among CD patients and from 0.588 to 0.712 among UC patients. The S-CVI/Ave was 0.98. Convergent validity analyses exhibited moderate to strong correlations between other measurements and IBD-Control-8-subscore (0.555-0.675) or IBD-Control VAS (0.503-0.671). Test-retest analysis showed that the mean scores were 75.23±17.33 versus 72.10±14.99 (r = 0.894, p<0.01) for VAS scores and 12.75±3.49versus 12.80±3.29 for IBD-Control-8 subscore (r = 0.963, p<0.01), respectively. The IBD-Control-8-subscore and IBD-Control-VAS exhibited significant discriminative capability among the PGA categories (ANOVA, p < .001). The ROC analysis revealed an optimal cut-off point for the IBD-Control-8 subscore of 14 points (sensitivity: 70.9%, specificity 83.5%), versus a cut-off of 70 on the IBD-Control VAS score (sensitivity: 84.4%, specificity 69.3%). The Chinese IBD-Control proves to be a disease-specific, reliable, and valid tool for revealing overall disease control from the patient's viewpoint. Both healthcare professionals and patients may find it to be a useful patient-reported outcome measurement for triaging IBD patients in China or complementing routine care.

Validation of the IBD-Control Questionnaire across different sociodemographic and clinical subgroups: Secondary analysis of a nationwide electronic survey.

The IBD-Control Questionnaire is a simple, generic measure of patient-perceived disease control used increasingly in clinical practice and research. We aimed to address knowledge gaps in its psychometric performance, to ensure that it can be used with confidence in a variety of contexts. We analysed 7,341 responses to the IBD Registry COVID-19 survey, sent to 40,911 patients who completed an online self-assessment tool during the pandemic. Questions covered demographics, comorbidities, IBD sub-type, IBD-Control Questionnaire and symptom scores (CD-PRO2 or UC-PRO2). Psychometric properties of IBD-Control-8 were tested overall and within subgroups (CD, UC and IBD-U; male and female; ≤65 and > 65 years; number of co-morbidities; deprivation status). Internal consistency was very strong overall (α: 0.84, ω: 0.89) and for each subgroup (α range: 0.81-0.85; ω: 0.86-0.90). Construct validity was demonstrated by moderate correlation of each item with global rating (VAS) (rs range: 0.47 to 0.65), strong correlation between IBD-Control-8 score and VAS (rs=0.74), moderate-to-strong with PRO2 scores (CD: rs = -0.718; UC: rs = -0.602) and significantly higher IBD-Control-8 scores for PRO2-remission versus -active, consistent across subgroups. Exploratory and Confirmatory Factor Analyses demonstrated a two-factor model (items loading onto 'Health-related Quality of Life' [HRQoL] or 'Treatment' domains). Extensive tests for factorial invariance confirmed consistency. IBD-Control-8 is a psychometrically robust scale which can be used across a range of populations. It offers a quick, reliable and valid method of assessing patient-perceived control. The construct of "control" includes traditional HRQoL and a novel domain relating to treatment perception.

The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease.

Despite growing awareness of the nocebo effect, few studies have evaluated the nocebo effect using combined assessment of patient-reported outcome measures (PROMs), clinical indices, and objective biomarkers in inflammatory bowel disease (IBD) patients switching from originator to biosimilar medicines. This study aimed to compare these outcomes across switch and non-switch cohorts to evaluate the nocebo effect in patients with IBD. Parallel cohorts of IBD patients who (1) switched from originator to biosimilar (CT-P13) infliximab and (2) continued biosimilar (CT-P13) infliximab were evaluated over 32 weeks. Clinical disease activity, objective biomarkers and PROMs were assessed at baseline, and weeks 16 and 32 across both cohorts. The PROM of interest was patient-perceived disease activity evaluated using a 0-100 visual analogue scale (VAS) per the IBD-Control Questionnaire. Of 81 patients, 47 switched from originator to biosimilar (CT-P13) infliximab. A negative change from baseline patient-reported disease control was observed across the switch cohort compared with the non-switch cohort at week 16 (mean VAS - 8.21 vs. 1.26; p=0.03), but not at week 32 (mean VAS - 1.21 vs. 1.38; p=0.58). Corresponding clinical and objective biomarker assessments over these timepoints were comparable across both cohorts. This study demonstrated a temporary yet discernible nocebo effect in the first 16 weeks following non-medical switching that was not sustained at week 32. Negative patient perceptions may be overcome by a patient-inclusive approach to non-medical switching in conjunction with close clinical follow-up and disease monitoring.

PROMOTING AT-HOME DISEASE MANAGEMENT OF IBD WITH A MULTIDISCIPLINARY DIGITAL THERAPY APP: SHORT-TERM RESULTS

Abstract BACKGROUND Although current concepts of disease management of Crohn’s Disease and ulcerative colitis (IBD) provide evidence of active engagement of patients, such a strategy is difficult to comply with unless multidisciplinary therapy is practiced. In the past years mobile and/or digital health solutions have proven to be competent tools to promote and retain self management for patients across many disease areas. The Nori Health mobile application was developed as multi-faceted digital therapy for IBD based on existing evidence in at-home management and treatment with the aim to accommodate multidisciplinary therapy remotely. OBJECTIVE The objective of this paper was to report on the retrospective short-term results of a multidisciplinary digital therapy app for the treatment and self-management of IBD; Nori Health. METHODS Nori Health is a mobile application that digitalizes multidisciplinary therapy, such as education, behavioral intervention and cognitive behavioral therapy (CBT), and is in the market as a CE class I medical device. For the current study, the internal data of anonymized Nori Health users was retrospectively analyzed. User data was evaluated for 8 weeks regarding duration of use (Figures 1, 2) and effect on in-app user reported disease management levels, using the short IBD Control questionnaire (IBD-CONTROL). RESULTS Data of 273 users were available, of which 29 users completed the IBD-CONTROL questionnaire both prior and after the duration of the analysis period. The gender of the users was 61% female and 39% male. Disease management levels increased 34% from baseline 50 to 67 for all users at the end of the observation period. CONCLUSION This retrospective study showed that in a randomized population of app users, an app digitalizing multidisciplinary interventions for the self-management of IBD improved user-reported disease management levels significantly. Additional RCTs will be needed to adjust for selection effects, potential bias, and to further improve clinical relevance of these short-term results.

Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period

IntroductionBiologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for...

The IBD-Control questionnaire: German translation and validation of the standardized questionnaire for Patient Reported Outcome Measurement in inflammatory bowel disease

Subjectively perceived results of treatment will be in the center of defining treatment success on the way to value-based and patient-centered health care. Patient-reported outcome measures (PROMs) serve as an instrument to measure treatment success. In inflammatory bowel disease (IBD), measuring treatment success from a patient's point of view is performed with the validated IBD-Control questionnaire. Because the IBD-Control questionnaire has not been published in German yet, the translation and validation of the IBD-Control in the German-speaking part of Switzerland was necessary before use. We have translated the English original version of the IBD-Control questionnaire into German in a state-of-the-art procedure of "forward-backward translation" and validated the translated IBD-Control questionnaire with 154 patients with Crohn's disease or with ulcerative colitis. Professional health care and translation experts have contributed to the translation of the IBD-Control into German. The IBD-Control-D is an accepted questionnaire. Spearmans Rho showed high consistency between the IBD-Control-8-Subscore and the IBD-Control-VAS-Score (r=0.632). The disease activity in the past 6 months highly correlated with the IBD-8 subscore (r=0.640) as well as with the IBD-Control-VAS-Score (r=0.622). The IBD-Control-8-Subscore highly correlated with the Harvey Bradshaw Index (r=-0.620) and the partial Mayo Score (r=-0.679), as well as the IBD-Control-VAS-Score with the Harvey Bradshaw Index (r=-0.484) and the Mayo Score (r=-0.435), showing sufficient construct validity. The result is the German version of the IBD-Control, the IBD-Control-D, published here. The original English version is a valid instrument, and its use has proven to be a suitable instrument in German-speaking areas to make the subjective feeling of illness and treatment outcome measurable.

OP22 Factors independently associated with fatigue in IBD: Results from the baseline dataset of the PREdiCCt study

Abstract Background Fatigue is one of the most common symptoms in IBD resulting in decreased quality of life, impaired work productivity, and higher societal costs. However, little is known about its etiology and pathophysiology. We aimed to estimate the prevalence of fatigue and to identify predictive factors for fatigue. Methods The PREdiCCt study (https://www.predicct.co.uk) is the largest prospective study of the causes of IBD flare. 2629 patients in clinical remission were recruited from 48 UK sites. 1946 (74%) patients completed the baseline questionnaires. We assessed the prevalence of fatigue at baseline using a single item from the IBD Control questionnaire. To identify predictors for fatigue, we performed univariable and multivariable analyses including demographic, biochemical, environmental and psychosocial factors such as anxiety and depression [HADS], sleep quality [PSQI] and physical exercise [GPAQ]). Results 759/1919 IBD patients in clinical remission (39.6%) reported fatigue in the past 2 weeks, while 1034 patients (53.9%) did not report fatigue. Patients who reported fatigue were more frequently female, had more frequently CD, and were more frequently smokers (Table 1). Univariable comparisons showed higher inflammatory markers in the fatigued group, with fewer patients in clinical remission. Multivariable analyses identified female sex (OR 2.4), CRP&amp;gt;5 (OR 2.1), bad sleep quality (OR 2.5), anxiety (OR 1.8) and depression (OR 6.2) as independent factors associated with fatigue (Table 2). Conclusion We show the significant burden of fatigue in IBD patients and describe putative causes which demonstrate both the impact of residual gut inflammation and the relationship between fatigue and psychological well-being. The impact of environmental and dietary factors on fatigue is being further investigated with ongoing longitudinal data collection in the PREdiCCt study.

P154 Faecal calprotectin and patient reported disease control of IBD: results from the baseline dataset of the PREdiCCt study

Abstract Background There is an established disconnect between intestinal inflammation and symptoms in patients with IBD. Faecal calprotectin (FCAL) is an excellent surrogate for mucosal healing and we have good data to support treat to target approaches based on FCAL. However, there is relatively little data analysing how well FCAL correlates with a fuller breakdown of a patient’s symptoms. We were interested to explore the impact of ongoing intestinal inflammation as measured by FCAL in patients reported to be in clinical remission. Methods The PREdiCCt study (https://www.predicct.co.uk) is the largest prospective study of the causes of IBD flare. 2629 patients in clinical remission were recruited from 48 UK sites and followed for 2 years. 1946 (74%) patients completed the baseline questionnaires. We present here the results of the baseline questionnaire analysis of IBD symptoms (IBD Control questionnaire). Eight of the question items generate a summary score (IBDControl-8) ranging from 0 (worst control) to 16 (best control). This questionnaire also includes a visual analogue scale (VAS) for disease control ranging from 0 (worst control) to 100 (best control). These data were matched to a contemporaneous FCAL measurements, taken at study entry. Results IBD Control-8 results are available in 1,919 patients [male=840, CD=985 UC/IBDU=934, age 45.8±15.5 (mean±SD in years)]). Median FCAL values were 46 mcg/g (IQR 20–150) for the overall cohort, 50 mcg/g (IQR 20–156) for CD and 39 mcg/g (IQR 20–143) for UC. UC patients reported better disease control compared to CD patients (p&amp;lt;0.001, for both IBDControl-8 and VAS). CD patients with previous surgery (p=0.031 for IBDControl-8) and perianal disease (p=0.015 and p=0.035, for IBDControl-8 and VAS respectively) reported worse disease control than the rest of the CD patients. Better disease control was reported in males versus female patients (p&amp;lt;0.001 and p=0.003 for IBDControl-8 and VAS respectively). There was a negative correlation between baseline FCAL values and (p&amp;lt;0.001). Patients who reported waking up at night due to their disease had higher FCAL values at baseline [median 60 mcg/g (IQR 20–162) vs 43 mcg/g (IQR 20–144), p=0.013] with the correlation being more prominent in UC (p=0.002). Patients who reported the need to change their treatment had higher FCAL values at baseline [85 mcg/g (IQR 24–336) vs 43 mcg/g (IQR 20–139), mcg/g, median (IQR), p=0.032]. Conclusion This is the first detailed symptom examination of clinical versus deep remission. We show how residual gut inflammation in patients in clinical remission affects meaningful patient reported outcomes measures including waking at night. UC and male patients reported better disease control compared to CD and female patients.

Cross-cultural translation and validation of the IBD-control questionnaire in The Netherlands: a patient-reported outcome measure in inflammatory bowel disease

Background There is a need for easy-to-use patient-reported outcome measures (PROMS) in inflammatory bowel disease (IBD) practice. The ‘IBD-control’ is a short IBD-specific questionnaire capturing disease control from the patient’s perspective. The International Consortium for Health Outcomes Measurement (ICHOM) recommends the use of the IBD-control even though it has only been validated in the United Kingdom. We aimed to cross-culturally translate and validate the IBD-control in the Netherlands using IBDREAM, a prospective multicentre IBD registry. Methods Lack of ambiguity and acceptability were verified in a pilot patient group (n = 5) after forward-backward translation of the IBD-control. Prospective validation involved completion of the IBD-control, Short Form-36, short IBDQ and disease activity measurement by Physician Global Assessment (PGA) and Simple Clinical Colitis Activity Index or Harvey-Bradshaw Index. Test–retest (2-week repeat) was used for measuring reliability. Results Questionnaires were completed by 998 IBD patients (674 Crohn’s disease, 324 ulcerative colitis). Internal consistency (Cronbach’s alpha) was 0.82 for the sub-group of 8 questions (IBD-control-8-sub-score). Mean completion time was 105 s. Construct validity analyses demonstrated moderate-to-strong correlations of the IBD-control-8-subscore and the other instruments (0.49-0.81). Test–retest reliability for stable patients was high (intraclass correlation coefficient 0.95). The IBD-control-8-subscore showed good discriminant ability between the PGA categories (ANOVA, p<.001). Sensitivity to change analyses showed large effect sizes of 0.81-1.87 for the IBD-control-8 subscore. Conclusions These results support the IBD-control as a rapid, reliable, valid and sensitive instrument for measuring disease control from an IBD patient’s perspective in the Netherlands.

473 The Prevalence and Burden of Rome IV Functional Colorectal Disorders in Ulcerative Colitis

INTRODUCTION: Despite advances in Ulcerative Colitis (UC) therapies, many patients suffer refractory symptoms in the absence of active inflammation. For this group, treatment remains challenging, with a paucity of therapeutic options. In this prospective, ongoing study, we aim to determine the prevalence and burden of functional colorectal disorders inpatients with quiescent UC. METHODS: In a cross-sectional study, consecutive patients with UC attending Inflammatory Bowel Disease (IBD) clinicscompleted a series of validated questionnaires; including Hospital Anxiety and Depression Scale (HADS), the Rome IV diagnostic questionnaire for functional gastrointestinal disorders (FGIDs), an IBD-QoL score and the IBD-control questionnaire. Participants were asked to return a Fecal Calprotectin (FCP) within 2 weeks of completing questionnaires. Quiescent UC was defined as IBD-control 8 score ≥13 and IBD-control-VAS ≥85, and/or FCP levels ≤250 (where available, FCP was used in preference to IBD-control to classify UC activity). Based on Rome IV diagnosis and UC disease activity (active or quiescent), patients were divided into groups and data compared using non-parametric tests. RESULTS: Overall, n = 97 UC patients (n = 50 males, mean age 48 (range 18-82)) participated. 41/97, (42%) UC patients met the Rome IV diagnostic criteria for ≥1 FGIDs (irritable bowel syndrome n = 26, functional constipation n=6 and faecal incontinence (FI) n = 22). Disease activity data (IBD-control and/or FCP) were available for all patients, and based on these 61/97, 63% had quiescent UC. Within the quiescent UC group, 25/61 (41%) met the Rome IV diagnostic criteria for ≥1 FGIDs (irritable bowel syndrome n = 14, functional constipation n = 3 and FI n = 13). In the active UC group, those with co-existing FGIDs, compared to those without FGIDs, had significantly worse median QoL scores (P = 0.02), higher HADS-depression (P = 0.005) and HADS-anxiety (P = 0.05). By contrast, in those with quiescent UC, those with an FGID did not have different median HADS scores (depression P = 0.15, anxiety P = 0.62) or IBD-QoL scores (P = 0.20), compared those without FGIDs. CONCLUSION: This study is one of the first to use Rome IV criteria in UC and confirms that the prevalence of FGIDs is high. Patients with active disease and overlapping functional symptoms appear to have worse QoL and more psychological distress compared to those with quiescent disease. Clinicians should be vigilant to this functional overlap and treat both functional and inflammatory driven symptoms.

758 The Hidden Burden of Faecal Incontinence in Active and Quiescent Ulcerative Colitis: An Underestimated Problem?

INTRODUCTION: Despite advances in Ulcerative Colitis (UC) therapies, many patients suffer refractory defecatory symptoms in the absence of active inflammation. For this group, treatment is challenging, with a paucity of research and limited therapeutic options. In this prospective, ongoing study, we aim to determine the prevalence of faecal incontinence (FI) in patients with quiescent UC. METHODS: In a cross-sectional study, consecutive patients with UC attending Inflammatory Bowel Disease (IBD) clinics completed a series of validated questionnaires; including an IBD-specific FI questionnaire (ICIQ-IBD questionnaire), Hospital Anxiety and Depression Scale (HADS), the Rome IV diagnostic questionnaire, and the IBD-control questionnaire. Participants were requested to return a Faecal Calprotectin (FCP) within 2 weeks of completing questionnaires. Quiescent UC was defined as IBD-control 8 score ≥13 and IBD-control-VAS ≥85, and/or FCP levels ≤250 (where available, FCP data were used in preference to IBD-control to classify UC activity). Data were compared between active and quiescent groups using chi-square and non-parametric tests. RESULTS: Overall, n = 97 UC patients (n = 50 males, mean age 48 (range 18-82) participated. ICIQ-IBD data revealed that most patients experience FI (84/97 (87%) during 'relapses'. Interestingly, 58/97 (60%) reported FI when in 'remission', and this group had higher median HADS depression (P = 0.0002), poorer QoL scores (P &lt; 0.0001), and trend towards higher HADS anxiety (P = 0.09) scores, compared to those without FI. Disease activity data (IBD-control and/or FCP) were available for all patients, and based on these 61/97 (63%) had quiescent UC. The prevalence of FI based on ICIQ-IBD did not differ between those with active (22/36, 61%) and quiescent UC (36/61, 59%), P = NS. In those with FI on ICIQ-IBD, median IBD-FI symptom scores, IBD-FI QoL scores and HADS (anxiety: P = 0.47, depression: P = 0.18) id not differ between disease activity groups. However, within the quiescent group, patients that met the more stringent Rome IV criteria for FI (n = 13) had higher median IBD-FI symptom scores (P = 0.007) and HADS-depression scores (P = 0.05), a trend to worse IBD-FI QoL (P = 0.07), but similar HADS-anxiety (P = 0.68). CONCLUSION: This is one of the first studies to identify that FI affects most patients with UC, regardless of disease activity, with a detrimental impact on patients' psychological wellbeing and QoL. FI be screened for in IBD clinics. There is an urgent need for further research in this area.

N809 IBD control questionnaire: validation and evaluation as part of a virtual biologic clinic in Galway University Hospital, Ireland

N809 IBD control questionnaire: validation and evaluation as part of a virtual biologic clinic in Galway University Hospital, Ireland

PTU-073 In Patients with IBD Switching from Originator Infliximab (Remicade) to Biosimilar Infliximab (CT-P13) Is Safe and Effective

Introduction Biosimilar infliximab (CT-P13) has been licensed for the treatment of IBD in Europe for over a year with the potential for significant cost savings. However, uptake in the UK has been slow primarily due to concerns over the lack of safety and efficacy data particularly with regard to switching patients from the originator product. We present the preliminary data from a controlled switch programme in a cohort of adult IBD patients. Methods A prospective study was undertaken to assess the safety and efficacy of switching patients receiving originator infliximab (Remicade) to its biosimilar (CT-P13). Patient demographic data was collected along with disease severity scores (HBI and SCCAI), biological markers of disease activity, drug and antibody levels and PROM data (IBD-Control questionnaire) prior to the switch and at each subsequent infusion visit. Evaluation of the efficacy of biosimilar infliximab at the time of the last infusion was compared with the originator at switch over. Means, medians, and ranges were calculated. Adverse events were prospectively collected. Results 78 IBD patients were included in the cohort (63 CD and 15 UC). The average age for the CD and UC patients was 43 and 42 years respectively. The average length of therapy on Remicade prior to the switch was 46 months for CD and 25 months for UC. 66/78 (85%) patients were receiving the standard dosage of 5 mg/kg 8 weekly with 12/78 (15%) either on a shortened interval or a 10 mg/kg dose. 42/63 (67%) of CD patients were in remission at switch over compared to 43/60 (72%) at the most recent infusion (4–6 months). The number of patients with mild, moderate and severe disease remained stable throughout the study period (Mild 10/63 (16%) v 11/60 (18%): Moderate 10/63 (16%) v 5/60 (8%): Severe 1/63 (2%) v 1/60 (2%)). 9/15 (60%) of UC patients were in remission at switch over compared with 11/13 (85%) at the most recent infusion. There was no difference in the mean CRP before and after the switch in either CD patients (5.4 vs 5.6 p=0.32) or UC patients (3.1 vs 3.0 p=0.73). The mean patient questionnaire score data also remained unchanged before and after the switch (CD 4.4 vs 4.0 p=0.56, UC 4.9 vs 3.1 p=0.61). Five patients (3 CD, 2 UC) discontinued infliximab during the study period (3 switched biological class, 1 infusion reaction, 1 deep remission). There were no adverse safety signals with one infusion reaction (1/283 infusions) and the rate of mild adverse events unchanged from before and after the switch. Conclusion Switching patients with IBD from originator infliximab to biosimilar infliximab appears both safe and effective. Wider uptake in the UK would result in considerable cost savings to the NHS. Disclosure of Interest None Declared